Status:
UNKNOWN
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Vulvar Cancer
Stage II Vulvar Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes....
Detailed Description
PRIMARY OBJECTIVES: I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure. OUTLINE: Patients re...
Eligibility Criteria
Inclusion
- Patients must have squamous cell carcinoma with a depth invasion \> 1 mm
- Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics\[FIGO\] staging), \< 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
- Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible
- Preoperative imaging do not show enlarged (\< 1.5 cm) suspicious nodes
- Patients must sign informed consent
Exclusion
- Inoperable tumors with diameter \> 4 cm
- Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (\> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
- Patients with multifocal tumors
- Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
Key Trial Info
Start Date :
January 3 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01500512
Start Date
January 3 2012
Last Update
September 30 2021
Active Locations (37)
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1
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
2
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
4
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136